Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE |
Generic Name | Device. Laser peripheral angioplasty |
Applicant | TRIMEDYNE, INC. 25901 COMMERCENTRE DR LAKE FOREST, CA 92630 |
PMA Number | P860042 |
Supplement Number | S014 |
Date Received | 01/10/1989 |
Decision Date | 07/21/1989 |
Withdrawal Date
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08/08/2012 |
Product Code |
LWX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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